Efficacy of Magnesium and Alpha Lipoic Acid Supplementation in Reducing Premature Uterine Contractions

December 16, 2013 updated by: AGUNCO Obstetrics and Gynecology Centre
To evaluate whether a combined supplementation of magnesium and lipoic acid is able to significantly reduce the incidence of uterine contractions and related episodes of hospitalization in pregnant women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary prevention of preterm labor is based on the early identification of risk factors and on appropriate treatments. Although several drugs are currently used, the identification of effective and safe agents able to improve both maternal and fetal health is still warranted.

In this study the efficacy a formulation based on magnesium and alpha-lipoic acid has been compared with placebo to evaluate the incidence of reduction of preterm delivery.

Three hundred pregnant women at 14-34 weeks of gestation were enrolled and randomly divided to receive a daily single tablet containing magnesium and alpha-lipoic acid supplement or placebo until delivery.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy
        • Clinica Villa delle Querce

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 41 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 14-34 weeks of gestation

Exclusion Criteria:

  • Preexisting diabetes mellitus
  • Systolic blood pressure >140mm Hg
  • Cancer
  • lupus
  • hepatitis
  • HIV/AIDS
  • Diagnosed alcohol or chemical dependency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: Magnesium + Lipoic Acid
Dietary supplement: Magnesium plus alpha-lipoic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of women with sporadic episodes of preterm uterine contraction
Time Frame: From baseline (beginning of the treatment) until delivery
From baseline (beginning of the treatment) until delivery
Number of women with frequent and persistent episodes of preterm uterine contractions associated with pain
Time Frame: From baseline (beginning of the treatment) until delivery
From baseline (beginning of the treatment) until delivery
Number of women needed for hospital admission for threatened preterm labour
Time Frame: From baseline (beginning of the treatment) until delivery
From baseline (beginning of the treatment) until delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGUNCO Obstetrics and Gynecology Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

December 20, 2013

Last Update Submitted That Met QC Criteria

December 16, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mg-ALA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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